目的:脑脊液漏是颅脑手术后的主要并发症,虽然纤维蛋白密封剂广泛用于加强硬脑膜闭合,对他们的安全存在担忧,功效,和成本。富白细胞和富血小板纤维蛋白(L-PRF),自体血小板浓缩物,是现成的和便宜的,使其成为市售纤维蛋白密封剂的具有成本效益的替代品。本研究旨在证明与市售纤维蛋白封闭剂相比,L-PRF在预防颅上和幕下手术术后脑脊液漏方面的非劣效性。次要结局集中在脑脊液漏的危险因素和不良事件上.
方法:在单盲中,prospective,在三级护理中心的神经外科部门进行的随机对照介入试验(UZLeuven,比利时),接受择期颅神经外科手术的患者被随机分配接受L-PRF(主动治疗)或市售纤维蛋白封闭剂(对照),以1∶1的比例封堵硬膜.
结果:在350名纳入的患者中,对328例进行了主要终点分析(44.5%为男性,平均年龄52.3±15.1岁)。6例患者(对照组5例,1在L-PRF组中)表现为需要任何干预的CSF泄漏(相对风险[RR]0.20,单侧95%CI-∞至1.02,p=0.11),确认非劣效性。在这6名患者中,1(对照组)出现CSF泄漏,需要进行翻修手术。未发现与L-PRF联合重建失败的危险因素。感染(0.72,95%CI-∞至1.96)和脑膜炎(0.36,95%CI-∞至1.25)等不良事件的RRs有利于L-PRF治疗,尽管L-PRF治疗显示出血事件稍多(1.44,95%CI-∞至4.66).
结论:使用L-PRF的硬脑膜加固被证明不劣于市售的纤维蛋白密封剂,没有安全问题。将L-PRF引入标准临床实践可能会由于可及性和较低的成本而导致重要的成本节省。临床试验登记号.:NCT03812120(ClinicalTrials.gov)。
OBJECTIVE: CSF leakage is a major complication after cranial surgery, and although fibrin sealants are widely used for reinforcing dural closure, concerns exist regarding their safety, efficacy, and cost. Leukocyte- and platelet-rich fibrin (L-PRF), an autologous platelet concentrate, is readily available and inexpensive, making it a cost-effective alternative for commercially available fibrin sealants. This
study aimed to demonstrate the noninferiority of L-PRF compared with commercially available fibrin sealants in preventing postoperative CSF leakage in supra- and infratentorial cranial surgery, with secondary outcomes focused on CSF leakage risk factors and adverse events.
METHODS: In a single-blinded, prospective, randomized controlled interventional
trial conducted at a neurosurgery department of a tertiary care center (UZ Leuven, Belgium), patients undergoing elective cranial neurosurgery were randomly assigned to receive either L-PRF (active treatment) or commercially available fibrin sealants (control) for dural closure in a 1:1 ratio.
RESULTS: Among 350 included patients, 328 were analyzed for the primary endpoint (44.5% male, mean age 52.3 ± 15.1 years). Six patients (5 in the control group, 1 in the L-PRF group) presented with CSF leakage requiring any intervention (relative risk [RR] 0.20, one-sided 95% CI -∞ to 1.02, p = 0.11), confirming noninferiority. Of these 6 patients, 1 (in the control group) presented with CSF leakage requiring revision surgery. No risk factors for reconstruction failure in combination with L-PRF were identified. RRs for adverse events such as infection (0.72, 95% CI -∞ to 1.96) and meningitis (0.36, 95% CI -∞ to 1.25) favored L-PRF treatment, although L-PRF treatment showed slightly more bleeding events (1.44, 95% CI -∞ to 4.66).
CONCLUSIONS: Dural reinforcement with L-PRF proved noninferior to commercially available fibrin sealants, with no safety issues. Introducing L-PRF to standard clinical practice could result in important cost savings due to accessibility and lower cost. Clinical
trial registration no.: NCT03812120 (ClinicalTrials.gov).